Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network (OUTMEDIC-FR)

February 22, 2023 updated by: Centre Hospitalier René Dubos

Description of the Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network

The aim of this study is to highlight action guidelines to encourage acceptance of deprescribing in people over 75 years of age: training, therapeutic education, post-prescription follow-up, specific patient pathways, specific consultations or even the integration of an advanced practice nurse in this process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For several years now, the proportion of senior citizens in our country has been rising steadily. There are now 6.4 million people over the age of 75 in France.

It is therefore important to take into account the needs and specificities of this part of the population. One of its particularities is polypathology. Indeed, from the age of 70 onwards, 93% of elderly subjects have at least 2 diseases and 85% have at least 3. This polypathology will lead to a large number of different prescribers with an increased risk of having more than 5 molecules in their personal treatment. This is known as polypharmacy.

In the elderly, polypharmacy is harmful. It increases the risk of adverse effects and drug interactions. In France, 20% of patients over 75 years old and 25% of those over 85 years old consult the emergency room because of adverse drug reactions.

The literature shows that we can act on these adverse events by "deprescribing". De-prescribing is defined as intentionally stopping the prescription of an unnecessary or potentially dangerous drug for a patient.

The expected benefit for the patient is to reduce the iatrogenic risks induced by treatments that would no longer be useful for him/her or that have a negative benefit/risk balance. To achieve this objective, the patient must understand this risk, understand the benefit he or she can derive from it and be an actor in this process.

For carers, the expected benefit is greater involvement of the patient in the process, better adherence to the approach, which can be organised and carried out in a safer way.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beauvais, France, 60021
        • Short stay Geriatric department - Hospital Simone Veil
      • Beauvais, France, 60021
        • SSR Geriatric department - Hospital Simone Veil
      • Pontoise, France, 95300
        • Short stay Geriatric department - Hospital René Dubos
      • Pontoise, France, 95300
        • SSR Geriatric department - Hospital René Dubos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 75 and over hospitalised in geriatric short stay or geriatric rehabilitation units

Description

Inclusion Criteria:

  • Patients aged 75 years and over
  • Hospitalized in geriatric short-stay or geriatric rehabilitation units
  • Patients who did not object to participation in the study

Exclusion Criteria:

  • Patient refusal
  • Patients not able to understand and fill in the questionnaire: Cognitive disorders, Confusion, Unstable clinical state, Sensory disorders, not speaking French.
  • Patient under protective supervision (guardianship or curatorship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Deprescribing
Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units
Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the obstacles to the withdrawal of medication in patients over 75 years of age in the geriatric sector
Time Frame: Baseline

The main evaluation criterion will be measured using the self-questionnaire: a revised form of the 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD), validated in French.

Discouragement will be assessed on the basis of the overall score of questions 1 to 20 of the self-questionnaire, with regard to questions 21 and 22.

Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the relationship between patient burden and acceptance (or refusal) of deprescribing.
Time Frame: Baseline

They will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items.

They will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items.

Baseline
Assessment of the relationship between the benefit of the treatment experienced by the patient and the acceptance (or refusal) of the deprescribing
Time Frame: Baseline
They will be measured using the self-questionnaire given to patients. Responses to the questions concerning the perceived benefit of treatment (questions 6 to 10) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items
Baseline
Assessment of the relationship between concern about possible negative effects of discontinuing treatment and acceptance (or refusal) of deprescribing
Time Frame: Baseline
They will be measured using the self-questionnaire given to patients. Responses to questions concerning concern about possible negative effects of stopping treatment (questions 11 to 15) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items.
Baseline
Assessment of the relationship between the patient's good knowledge of their treatments and acceptance (or refusal) of the deprescribing.
Time Frame: Baseline
They will be measured using the self-questionnaire given to patients. The answers to the questions concerning the patient's good knowledge of their treatments (questions 16 to 20) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items..
Baseline
Assessment of the relationship between certain families of treatments and acceptance (or refusal) of deprescribing
Time Frame: Baseline
They will be measured using the self-questionnaire given to patients. Responses concerning the acceptance of deprescribing according to the different treatment families will be measured using simple questions 26 to 29 of the self-questionnaire
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christophe Antoniazzi, Hospital René Dubos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

January 25, 2023

Study Completion (Actual)

January 25, 2023

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CHRD2921
  • 2022-A00136-37 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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